AMPLEX Ankle Fusion and Hindfoot (NCT03028415) | Clinical Trial Compass
CompletedNot Applicable
AMPLEX Ankle Fusion and Hindfoot
United States56 participantsStarted 2017-07-28
Plain-language summary
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion Criteria:
* Signed written informed consent
* Indicated for ankle or hindfoot arthrodesis and require one of the following arthrodesis procedures:
Tibiotalar (ankle); Talocalcaneal (subtalar); Talonavicular; Calcaneocuboid; Double hindfoot (e.g., talonavicular and talocalcaneal joints); Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints)
* Presents with pain on weight-bearing of at least 40 mm on a 100 mm VAS at the area indicated for arthrodesis
* Presents with at least one comorbid risk factors that warrant the use of supplemental autogenous bone or allograft:
Radiographic evidence of bone defect, deficit, subsidence or subchondral cyst; More than one joint to be fused; Involvement of other adjacent or nonadjacent joints; Large surface area; Intra-articular or extra-articular deformity; Post-traumatic arthritis; Diagnosis of osteoporosis
* The Investigator determines if the joint space(s) can be adequately filled with graft material (AMPLEX or ABG) according to the following parameters:
Single hindfoot joint fusion: up to 5 cm\^3; Double or triple hindfoot fusion: each individual joint up to 5 cm\^3, but overall, not more than 10 cm3 for the full complement of joints; Ankle fusion: up to 10 cm\^3
* Each fused joint can be rigidly stabilized with with at least 1 and no more than 3 screws across the fusion plane. (Supplemental pins and staples may be used, as well as supplemental screws and plates external to the fusion site(s))
* Willing and …
What they're measuring
1
Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint